LUXSOL(TM) Topical Cream for the Treatment of Symptomatic Bacterial Vaginosis; A Proof of Concept Study

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: CDA Research Group, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

LUXSOL Cream may be useful for the treatment of bacterial Vaginosis. In this study, LUXSOL Cream is compared to a control arm group using metronidazole cream. LUXSOL is administered intravaginally for 10 days, each evening before bedtime to treat bacterial Vaginosis..

Research Team

Eligibility Criteria

Inclusion Criteria

Subject agrees to participate and signs informed consent

Female age 18 or older

Subject has clinical BV with 4 of 4 Amsel's criteria

Treatment Details

Interventions

• LUXSOL (Antibacterial Agent)
• Metronidazole (Antibacterial Agent)

Participant Groups

Group I: LUXSOL Cream Experimental Treatment 1 Intervention

LUXSOL Cream is a copper containing cream to be administered intravaginally before bedtime for 10 consecutive nights.

Group II: Metronidazole cream Active Control 1 Intervention

Metronidazole cream is the active comparator drug to be self-administered intravaginally each night before bedtime for 10 consecutive nights. Dosage is per package insert.

Who Is Running the Clinical Trial?

CDA Research Group, Inc.

Lead Sponsor

Trials

5

Recruited

290+